Ex Parte Fine et alDownload PDFPatent Trial and Appeal BoardDec 1, 201713017768 (P.T.A.B. Dec. 1, 2017) Copy Citation United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/017,768 01/31/2011 David H. Fine 16250.0022 7301 27890 7590 12/05/2017 STEPTOE & JOHNSON LLP 1330 CONNECTICUT AVENUE, N.W. WASHINGTON, DC 20036 EXAMINER SUL, DOUGLAS YOUNG ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 12/05/2017 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): hfox @ steptoe. com ipdocketing @ steptoe.com lfielding @ steptoe.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DAVID H. FINE, RYAN DENTON, GREGORY VASQUEZ, and BRYAN JOHNSON Appeal 2017-011502 Application 13/017,768 Technology Center 3700 Before ANNETTE R. REIMERS, THOMAS F. SMEGAL, and GORDON D. KINDER, Administrative Patent Judges. REIMERS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE1 David H. Fine et al.2 (Appellants) appeal under 35 U.S.C. § 134(a) from the Examiner’s decision to reject under 35 U.S.C. § 103(a) claims 1—4, 1 The Examiner objected to independent claims 1 and 21 due to “informalities.” See Final Act. 2 (dated Mar. 7, 2016). Appellants submitted an Amendment After Final Action proposing to amend claims 1 and 21 to correct the informalities. See Amendment After Final Action, 1—4 (filed June 7, 2016). In the Advisory Action, the Examiner states that “the proposed amendment(s)” “will be entered.” Adv. Act. Summary Sheet PTOL—303 (dated July 26, 2016). Accordingly, the Examiner’s objection to the claims is moot. 2 We are informed that the real party in interest is GeNO LLC. Br. 3 (filed Mar. 7, 2017.) Appeal 2017-011502 Application 13/017,768 6—8, 10, 11,21, 24—27, 29, and 30 as unpatentable over Fine (US 2008/0317874 Al, published Dec. 25, 2008), Stenzler (US 2006/0207594 Al, published Sept. 21, 2006), McRae (US 6,766,220 B2, issued July 20, 2004), Woolfenden (US 6,564,656 Bl, issued May 20, 2003), Rounbehler (US 2006/0048779 Al, published Mar. 9, 2006), and Kertzman (US 3,521,865, issued July 28, 1970). Claims 5, 9, 12—20, 22, 23, 28, and 31 have been canceled. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. CLAIMED SUBJECT MATTER The claimed subject matter relates to a system and a method “of using liquid nitrogen dioxide (N2O4) with a ventilator to generate and deliver nitric oxide to a patient.” Spec. 12, Fig. 2. Claims 1 and 21 are independent. Claim 1 is illustrative of the claimed subject matter and recites: 1. A system for delivering a therapeutic amount of nitric oxide (NO) comprising: a ventilator configured to deliver a gas including oxygen or air; a liquid reservoir containing dinitrogen tetroxide; a tube directly connected to the reservoir configured to release nitrogen dioxide (NO2) gas vaporized from the dinitrogen tetroxide in the reservoir into the gas to obtain a gas-nitrogen dioxide mixture including nitrogen dioxide at an amount higher than a therapeutic amount of nitric oxide, wherein the tube has a bore diameter size of less than 10 microns, wherein the therapeutic amount is an amount to be delivered to a patient, wherein a flow rate from the tube is controlled by a differential pressure, the bore diameter size and a length of the tube, and wherein the amount of NO delivered to a patient does not fluctuate more than 10 ppm between a highest concentration and a lowest concentration when connected to the ventilator; 2 Appeal 2017-011502 Application 13/017,768 a first receptacle coupled to the tube, wherein the receptacle comprises an antioxidant capable of converting the nitrogen dioxide gas into nitric oxide, a heating element associated with the reservoir to control a temperature of the reservoir so that only NO2 vapor is introduced into the oxygen or air flow; and a patient interface coupled to the first receptacle, wherein the patient interface is adapted to deliver the therapeutic amount of nitric oxide. ANALYSIS Appellants do not offer arguments in favor of independent claim 21 or dependent claims 2-4, 6—8, 10, 11, 24—27, 29, and 30 separate from those presented for independent claim 1. See Br. 5—10. We select claim 1 as the representative claim, and claims 2—4, 6—8, 10, 11,21, 24—27, 29, and 30 stand or fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). Claim 1 recites “[a] system for delivering a therapeutic amount of nitric oxide (NO)” “wherein the amount of NO delivered to a patient does not fluctuate more than 10 ppm between a highest concentration and a lowest concentration when connected to the ventilator.” Br. 12, Claims App. Appellants contend that “Stenzler does not meet the first condition to qualify as analogous art.” Id. at 7. In particular, Appellants contend that Stenzler is not from the same field of endeavor as the present invention. The claimed invention relates to a system and a method for generating a steady flow of [nitric dioxide (NO2)] into the air system when connected to a ventilator that pulses air into the lungs (see paragraph [0020]). Paragraph [0032] and FIG. 2 [of the subject invention] disclose that the claimed invention shows a peak to peak noise of 10 ppm. Stenzler teaches a device for delivering [nitric oxide (NO)] to a patient in a pulsed flow, alternating two different concentrations (i.e. a high concentration and a low concentration) 3 Appeal 2017-011502 Application 13/017,768 of nitric oxide containing gas. See Stenzler, Abstract. Specifically, Stenzler teaches that the high concentration is preferably between 160 ppm to 200 ppm, and the low concentration is preferably between 20 ppm to 40 ppm (see Stenzler, paragraphs [0026] and [0134]). In other words, Stenzler teaches away from minimizing the fluctuation between the high concentration and the low concentration to no more than 10 ppm when a ventilator is connected to a NO delivery system. Rather, Stenzler teaches that the difference between the high concentration and the low concentration is preferably as much as 180ppm (= 160 ppm — 20 ppm). Br. 7-8. Appellants further contend that “Stenzler also fails to meet the second condition to quality as analogous art — it is not reasonably pertinent to the problem faced by the present inventors.” Id. at 8. In particular, Appellants contend that “Stenzler’s wide fluctuation between the high concentration and the low concentration of [nitric oxide (NO)] is opposite to the [sic.] solving the present inventors’ problem of minimizing the fluctuation between the high concentration and the low concentration.” Id. at 9. The two separate tests for determining whether a prior art reference is analogous are: (1) whether the art is from the same field of endeavor, regardless of the problem addressed; and (2) if the reference is not within the inventor’s field of endeavor, whether the reference is reasonably pertinent to the particular problem with which the inventor is involved. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)(citing In re Deminski, 796 F.2d 436, 442 (Fed.Cir.1986) and In re Wood, 599 F.2d 1032, 1036 (CCPA 1979)). In response Appellants’ first argument, the Examiner correctly points out that “both Stenzler and Appellants’] invention [are] directed to devices to deliver nitric oxide in a breathing gas to be inhaled by a patient” and that 4 Appeal 2017-011502 Application 13/017,768 “in an embodiment of Stenzler, a method of delivering a constant concentration of nitric oxide to a mechanically ventilated patient” is disclosed in paragraph 31 of Stenzler. See Ans. 13.3 The Examiner properly reasons that “[bjecause both Stenzler and Appellants’] invention are directed to systems for delivering a therapeutic amount of [nitric oxide (NO)] for inhalation by the patient, both Stenzler and Appellants’] invention are considered to be from the same field of endeavor of the invention.” Id. In other words, the Examiner finds that Stenzler is within Appellants’ field of endeavor. Appellants do not provide persuasive evidence or argument apprising us of error in the Examiner’s findings. Further, in response to Appellants’ second argument, the Examiner clarifies that “[t]he primary reference Fine discloses an air pump providing a flow of gas for inhalation to a patient. Fine does not disclose that the air pump is a ventilator” and that “Stenzler is relied upon to teach that ventilators are well-known in the art to provide a breathable gas to a patient in [nitric oxide (NO)] delivery device (the source of diluent gas can also be a ventilator, air pump, blower, or other mechanical device that moves breathable air).” Ans. 14 (citing Stenzler 1133). The Examiner reasons that it would have been considered obvious to the skilled artisan, upon seeing Stenzler’s disclosure, to substitute Fine’s air pump with a ventilator, as the use of a ventilator, air pump, blower, or other mechanical device are well-known in the art for the purpose of delivering a medically beneficial amount and sequence of air to a patient. 3 Dated June 23, 2017. 5 Appeal 2017-011502 Application 13/017,768 Ans. 14. The Examiner’s findings are sound and supported by a preponderance of the evidence, and the Examiner’s conclusions therefrom are based on rational underpinnings. Appellants do not provide persuasive evidence or argument apprising us of Examiner error. Moreover, Appellants’ arguments are attacks on the references individually where the Examiner’s rejection is based on the combined teachings of references. See In re Keller, 642 F.2d 413 (CCPA 1981); In re Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986)). As clarified by the Examiner in the Answer, the Examiner relies on Stenzler merely for disclosing that “ventilators are well-known in the art to provide a breathable gas to a patient in [nitric oxide (NO)] delivery device (the source of diluent gas can also be a ventilator, air pump, blower, or other mechanical device that moves breathable air).” Ans. 14 (citing Stenzler |133). Stated differently, the Examiner is merely proposing “to substitute Fine’s air pump with [Stenzler’s] ventilator.” Id. The Examiner relies on Kertzman, not Stenzler, for disclosing that the amount of nitric oxide (NO) delivered to a patient does not fluctuate more than 10 ppm between a highest concentration and a lowest concentration. See Final Act. 7—8, 13—14; see also Ans. 14—16. Thus, Appellants’ argument that Stenzler fails to disclose that “the difference between the high concentration and the low concentration” is “no more than 10 ppm” is unpersuasive. See Br. 8. Appellants contend that [i]t is the Examiner’s unfounded speculation that Kertzman can be applied to provide this teaching. Kertzman teaches a device for the generation of an accurately known vapor concentration by permeation, where the device is controlled to produce an accuracy of ±2-3%. [Appellants] respectfully submit that “±2~3%” in Kertzman is a relative value that cannot be directly 6 Appeal 2017-011502 Application 13/017,768 compared with an absolute value of “10 ppm” in the claims. For example, “±2~3%” in Kertzman can be much higher than 10 ppm if the vapor concentration is higher than 500 ppm. Moreover, Kertzman’s device is not connected to a ventilator and does not provide teaching how to maintain the vapor concentration within 10 ppm range when connected to a ventilator. Br. 9. As an initial matter, claim 1 recites nothing about “10 ppm” being “an absolute value.” See Br. 9; see also id. at 12, Claims App.; In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (Limitations not appearing in the claims cannot be relied upon for patentability). Further, as discussed above, the Examiner relies on Stenzler for disclosing “a ventilator” and proposes “substituting] Fine’s air pump with [Stenzler’s] ventilator.” Ans. 14; see also Final Act. 4. Appellants do not provide persuasive evidence or argument apprising us of Examiner error. See Br. 6—9. Here, the Examiner finds that the modified Fine device (i.e., Fine in view of the teachings of Stenzler, McRae, Woolfenden, and Rounbehler) “does not disclose the amount of [nitric oxide (NO)] delivered to a patient does not fluctuate more than 10 ppm between a highest concentration and a lowest concentration when connecter to a ventilator.” Final Act. 7; see also id. at 13—14. The Examiner finds that Kertzman discloses a device “controlled to produce an accuracy of ±2% at a volume of 25 ppm and an accuracy of ±3% at a volume of 250 to 1500 ppm.” Final Act. 7 (citing Kertzman 3:14—29); see also id. at 13—14. The Examiner concludes that it would have been obvious to further modify Fine’s device “by controlling the diffusion rate so that the amount of [nitric oxide (NO)] delivered to a patient is within +3% as taught by Kertzman in order to accurately provide a gas of 7 Appeal 2017-011502 Application 13/017,768 a known vapor concentration.” Final Act. 8 (citing Kertzman 1:13—25); see also id. at 14. The Examiner states that “[a]s the amount of [nitric oxide (NO)] delivered to a patient [in Fine] is 40 ppm, the amount delivered fluctuates by ±3%, which would be less than 10 ppm (+1.2 ppm).” Final Act. 8; see also Ans. 15 (“[W]hen Fine’s device is used at its disclosed operating value, an accuracy of ±2-3% would be within 10 ppm (+1.2 ppm).”). Based on our understanding of the Examiner’s findings, the 40 ppm of nitric oxide (NO) delivered to a patient in Fine represents the mean value and the modified Fine device, in view of Kertzman’s teachings, would fluctuate between a highest concentration of 41.2 ppm and a lowest concentration of 38.8 ppm (i.e., ±1.2 ppm), which is not more than 10 ppm. As such, the Examiner properly concludes that “the [modified] device of Fine, [as further] modified with the teaching of Kertzman, when operated according to Fine’s disclosure, would meet the limitation of not fluctuating more than 10 ppm between a highest and lowest concentration when connected to a ventilator (±1.2 ppm).” Ans. 15. Appellants do not provide persuasive evidence or argument apprising us of Examiner error. See Br. 9—10. That Stenzler and Kertzman may teach additional structure does not prevent the Examiner from relying on each reference for limited purposes. “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference, but rather whether a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention.” Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, 825 F.3d 1373, 1381 (Fed. Cir. 2016) (internal citations and quotation 8 Appeal 2017-011502 Application 13/017,768 marks omitted). Appellants do not provide persuasive evidence or argument apprising us of error in the Examiner’s proposed reasoning based upon the combined teachings of Fine, Stenzler, McRae, Woolfenden, Rounbehler, and Kertzman. See Br. 6—10. Appellants contend that “the claim language sufficiently describes how to enable the claimed invention. The specification discloses that ‘. . . [t]he heated N2O4 source can leak a precisely controlled amount of NO2 into the air/oxygen stream that leaves the ventilator.’” Br. 10. (citing Spec. 126). Appellants conclude that “[t]he Examiner fail[s] to state what other essential elements to enable the claimed invention are missing in the claims.” Id. As an initial matter, we note that limitations not appearing in the claims cannot be relied upon for patentability. See In re Self, 671 F.2d at 1348. There is no recitation in claim 1 of the above cited language from paragraph 26 of the Specification. We further note that the Examiner does not propose an enablement rejection of the claims. See Final Act. 2-13. Upon a thorough review of the record before us, we believe Appellants are responding to a statement made by the Examiner at page 2 of the Advisory Action (i.e., “[Appellants do] not recite any additional structure in the claims that enables [Appellants’] invention to provide a concentration that does not fluctuate by more than 10 ppm between a highest concentration and a lowest concentration when connected to a ventilator.”). Based on our understanding, the Examiner’s position is that Appellants have not recited “additional structure in the claims” to overcome the Examiner’s proposed combination based upon the teachings of Fine in view of Stenzler and Kertzman. See Adv. Act. 2. 9 Appeal 2017-011502 Application 13/017,768 As discussed above, the Examiner relies on Stenzler for disclosing “a ventilator” and proposes “substituting] Fine’s air pump with [Stenzler’s] ventilator.” Ans. 14; see also Final Act. 4. Appellants do not provide persuasive evidence or argument apprising us of Examiner error. See Br. 6— 9. As further discussed above, we agree with the Examiner’s conclusion that “the [modified] device of Fine, [as further] modified with the teaching of Kertzman, when operated according to Fine’s disclosure, would meet the limitation of not fluctuating more than 10 ppm between a highest and lowest concentration when connected to a ventilator (±1.2 ppm).” Ans. 15. Appellants do not provide persuasive evidence or argument apprising us of Examiner error. See Br. 9-10. Appellants further do not apprise us as to “what other essential elements” to the claimed invention are missing from the Examiner’s proposed rejection based upon the combined teachings of Fine, Stenzler, McRae, Woolfenden, Rounbehler, and Kertzman. See Br. 6— 10; see also Final Act. 3—8, 13—14; Adv. Act. 2; Ans. 14—16. Additionally, in response to Appellants’ argument, the Examiner finds that Kertzman discloses a device for generating a known vapor concentration by which the amount of gas delivered is determined by the pressure of the gas, the temperature of the system, the tube wall thickness, and the tube length (Kertzman, col 2, In 51-60). Kertzman operates in the same manner as Appellants’] device (by providing precisely controlled amount of vapor in a gas stream based on the gas pressure, temperature, and properties of the diffusion tube including its length), and ventilators are known in the art to provide a flow of air [as disclosed in Stenzler], therefore, the modified Fine’s device [as further] modified with the teaching of Kertzman is considered to provided amount of NO delivered to a patient which does not fluctuate by more than 10 ppm between a highest concentration 10 Appeal 2017-011502 Application 13/017,768 and a lowest concentration when connected to a ventilator as recited in claim[] 1. Ans. 15; see also id. at 13; Final Act. 4, 7—8, 13—14; Adv. Act. 2. The Examiner’s findings are sound and supported by a preponderance of the evidence, and the Examiner’s conclusions therefrom are based on rational underpinnings. Appellants do not provide persuasive evidence or argument apprising us of Examiner error. Moreover, to the extent Appellants are arguing that there would be no reasonable expectation of success in the Examiner’s proposed combination of the teachings of Fine, Stenzler, McRae, Woolfenden, Rounbehler, and Kertzman, Appellants have not explained with any specificity why a person of ordinary skill in the art would not have had an expectation of success in making the proposed modifications. See Br. 6—10; see also Final Act. 3—8, 13—14; Adv. Act. 2; Ans. 14—16; In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988) (noting that all that is required is a reasonable expectation of success, not absolute predictability of success). Accordingly, and based on the record presented, we are not persuaded the Examiner erred in rejecting independent claim 1 as obvious over Fine, Stenzler, McRae, Woolfenden, Rounbehler, and Kertzman. We sustain the Examiner’s rejection of claim 1 as obvious over Fine, Stenzler, McRae, Woolfenden, Rounbehler, and Kertzman. We further sustain the Examiner’s rejection of claims 2-4, 6—8, 10, 11,21, 24—27, 29, and 30, which fall with claim 1. 11 Appeal 2017-011502 Application 13/017,768 DECISION We AFFIRM the decision of the Examiner to reject claims 1—4, 6—8, 10, 11,21, 24—27, 29, and 30 as unpatentable over Fine, Stenzler, McRae, Woolfenden, Rounbehler, and Kertzman. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 12 Copy with citationCopy as parenthetical citation